From the Guidelines
Entresto (sacubitril/valsartan) can cause several potential side effects, including low blood pressure (hypotension), elevated blood potassium levels (hyperkalemia), kidney problems, and angioedema, a serious allergic reaction that requires immediate medical attention. These side effects are critical for patients to be aware of, especially considering the medication's mechanism of action, which combines an angiotensin receptor blocker (valsartan) with a neprilysin inhibitor (sacubitril) to reduce strain on the heart and improve heart failure symptoms 1.
Common Side Effects
- Low blood pressure (hypotension), which may cause dizziness or lightheadedness, especially when standing up
- Elevated blood potassium levels (hyperkalemia)
- Kidney problems, particularly decreased kidney function
- Cough
- Fatigue
- Diarrhea
- Nausea
- Headache
Serious Side Effects
- Angioedema, a serious allergic reaction causing swelling of the face, lips, tongue, and throat that requires immediate medical attention
Contraindications and Cautions
Patients with a history of angioedema or those taking ACE inhibitors should not take Entresto (ACE inhibitors must be discontinued at least 36 hours before starting Entresto) 1. Pregnant women should avoid this medication as it can harm the developing fetus, particularly in the second and third trimesters. The starting dose should be adjusted in patients with severe renal impairment (eGFR <30 mL/min/1.73 m2) or moderate hepatic impairment, to 24/26 mg twice daily, with dose doubling every 2–4 weeks to target the maintenance dose of 97/103 mg twice daily, as tolerated 1.
Monitoring and Patient Education
Patients should be educated about postural hypotension and the importance of monitoring blood pressure and renal function while on Entresto 1. They should report any concerning symptoms to their healthcare provider promptly, especially severe dizziness, fainting, swelling, or difficulty breathing.
From the FDA Drug Label
• Serious allergic reactions causing swelling of your face, lips, tongue, and throat (angioedema) that may cause trouble breathing and death. • Low blood pressure (hypotension). • Kidney problems • Increased amount of potassium in your blood (hyperkalemia). The most common side effects of sacubitril and valsartan tablets also include cough and dizziness.
The potential side effects of Entresto (sacubitril/valsartan) include:
- Serious allergic reactions (angioedema)
- Low blood pressure (hypotension)
- Kidney problems
- Increased blood potassium levels (hyperkalemia)
- Cough
- Dizziness 2
From the Research
Potential Side Effects of Entresto (Sacubitril/Valsartan)
The potential side effects of Entresto (sacubitril/valsartan) include:
- Increased risk of angioedema, a condition characterized by swelling of the face, lips, tongue, or throat [ 3, 4, 5, 6, 7 ]
- Hyperkalemia (high potassium levels in the blood), which can be serious and even life-threatening [ 3, 4, 5, 6 ]
- Hypotension (low blood pressure), which can cause dizziness, lightheadedness, or fainting [ 3, 4, 5, 6 ]
- Renal impairment, including acute kidney injury or worsening of existing kidney disease [ 3, 4, 5, 6, 7 ]
- Increased risk of nonserious adverse reactions, such as cough, fatigue, or diarrhea [ 3 ]
Common Adverse Reactions
Common adverse reactions to Entresto (sacubitril/valsartan) include:
- Dizziness or lightheadedness
- Fatigue or weakness
- Cough
- Diarrhea
- Increased potassium levels in the blood
- Decreased renal function or kidney damage
Serious Adverse Reactions
Serious adverse reactions to Entresto (sacubitril/valsartan) include:
- Angioedema, which can be life-threatening
- Hyperkalemia, which can cause serious heart problems or even death
- Hypotension, which can cause dizziness, lightheadedness, or fainting
- Renal impairment, including acute kidney injury or worsening of existing kidney disease
Special Populations
Special populations, such as older adults or those with kidney disease, may be more susceptible to the side effects of Entresto (sacubitril/valsartan) [ 4, 5, 6 ].